HER2 Support Group Forums - View Single Post - HER2 amplification predicts breast cancer recurrence but not overall survival

gdpawel · 02-03-2009, 09:30 PM

All I'm saying is there's no single gene whose expression accurately predicts therapy outcome.

I wouldn't see a problem trying to get private insurance companies to reimburse for functional profiling tests (Medicare already does). When you get to the new genetic/molecular profiling tests, the validation standard that private insurance companies is accepting for reimbursement is "accuracy" and not "efficacy." The essential "proof" is that all they have to do for these tests is that the test has a useful degree of "accuracy," not that the use of the diagnostic test improves clinical outcomes.

That's the exact same existing validation for every single test used in cancer medicine, from estrogen receptors to panels of immunohistochemical stains (IHC) to diagnosing and classifying tumor to Her2/neu and CA-125 to functional profiling tests (oncologic in vitro chemoresponse assays) to MRI's, CT Scans, Pet Scans and so on. All diagnostic tests have the same entitlement to be judged by the same validation standard as genetic/molecular profiling tests.

02-03-2009, 09:30 PM	#4
gdpawel Senior Member Join Date: Aug 2006 Location: Pennsylvania Posts: 1,080	reimbursements All I'm saying is there's no single gene whose expression accurately predicts therapy outcome. I wouldn't see a problem trying to get private insurance companies to reimburse for functional profiling tests (Medicare already does). When you get to the new genetic/molecular profiling tests, the validation standard that private insurance companies is accepting for reimbursement is "accuracy" and not "efficacy." The essential "proof" is that all they have to do for these tests is that the test has a useful degree of "accuracy," not that the use of the diagnostic test improves clinical outcomes. That's the exact same existing validation for every single test used in cancer medicine, from estrogen receptors to panels of immunohistochemical stains (IHC) to diagnosing and classifying tumor to Her2/neu and CA-125 to functional profiling tests (oncologic in vitro chemoresponse assays) to MRI's, CT Scans, Pet Scans and so on. All diagnostic tests have the same entitlement to be judged by the same validation standard as genetic/molecular profiling tests.